Hepatitis C Infection
Conditions
Brief summary
This study is aimed at assessing the safety of candidate Hepatitis C (Hep C) vaccines AdCh3NSmut1 and MVA-NSmut when administered to Human Immunodeficiency Virus (HIV) seropositive individuals. This study also aims to assess the cellular immune response generated by these vaccines when administered as mentioned above.
Detailed description
Hepatitis C (Hep C) is a common infection. Worldwide, over 180 million people are infected. Hep C is a blood borne viral infection spread through direct contact with the blood of an infected person. People with Hep C frequently have no symptoms and infection can lead to fibrosis (scarring of the liver), liver failure and cancer. Infection with the Hep C virus (HCV) progresses more rapidly to liver damage in Human Immunodeficiency Virus (HIV)-infected individuals. Researchers at the University of Oxford have developed a novel candidate vaccine against HCV ('NSmut'). This vaccine has been inserted into the carrier viruses Chimpanzee Adenovirus 3 (AdCh3) and modified vaccinia virus Ankara (MVA), both of which have excellent safety records and have been previously tested in people. However, the objective of this study is to use exploratory immunological assays to assess whether vaccines for Hep C can induce immune responses in HIV positive individuals that are similar in strength to those in healthy volunteers.
Interventions
BIOLOGICALAdCh3NSmut1
Genetic vaccine against Hepatitis C virus infection
BIOLOGICALMVA-NSmut
Genetic vaccine against Hepatitis C virus infection
Sponsors
GlaxoSmithKline
ReiThera Srl
Cantonal Hospital of St. Gallen
St. James's Hospital, Ireland
University of Oxford
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* HIV-1 seropositive adults must satisfy all the following inclusion criteria to be eligible for the study: * Aged 18 to 60 years (inclusive) * Resident in or near the trial sites for the duration of the vaccination study for the participant * Able and willing (in the Investigator's opinion) to comply with all study requirements * HIV Viral Load \<50 copies/mL at the last routine HIV follow-up visit within the last 9 months prior to inclusion whilst on treatment with an effective ART regimen * Willingness to remain on ART for the study duration * CD4 cell count above 350 cells/uL * Negative HCV serology and negative HCV RNA polymerase chain reaction (PCR) testing * For women of child bearing potential, willingness to practise continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. In subjects on ART, these are: * Injectable progestogen * Male partner sterilisation prior to the female subject's entry into the study, and this male is the sole partner for that subject * Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository) * Intrauterine device or intrauterine system * In addition male partners should use condoms until 3 months after the last vaccination * Male trial participants with a female partner of child bearing potential should use condoms until 3 months after the last vaccination. In addition, the female partner should use one of the following contraceptive methods, i.e. * Oral or injectable hormonal contraception * Sterilisation * Intrauterine device or intrauterine system * Male trial participants with pregnant partners should use condoms until 3 months after the last vaccination * Written informed consent
Exclusion criteria
* HIV-1 seropositive adults may not enter the study if any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of administering HCV prime-boost vaccinations to HIV seropositive individuals, as measured by the proportion of participants who develop a grade 3 or 4 local or systemic reaction | From Day 0 until 6 months after the last vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cellular immune response generated by HCV prime-boost vaccinations in HIV seropositive individuals, as determined by analysing changes in the magnitude or quality of HCV-specific cellular immune responses | From Day 0 until 6 months after the last vaccination | Immunogenicity determined by analysing changes from baseline in the magnitude or quality of HCV-specific cellular immune responses. The primary outcome measure for immunogenicity will be the development of T cell responses to HCV epitopes, as determined by Interferon (IFN)-ɣ Enzyme-Linked ImmunoSpot (ELISpot) assay. |
Countries
Ireland, Switzerland
Outcome results
None listed